Trial · NCT02559687
Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)
NCT02559687, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2019-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180). Trials, record NCT02559687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02559687
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)
- NCT number
- NCT02559687
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Esophageal Carcinoma, Esophagogastric Junction Carcinoma
- Interventions
- pembrolizumab
- First posted
- 2015-09-24
- Last updated
- 2022-09-14
- Other registries' IDs
- eudract:2015-002427-26
- Results first posted
- 2019-07-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) | Up to approximately 28 months | ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was reported per protocol for the first course of treatment. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 59 months | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced ≥1 AE was reported per protocol for the first course of treatment. |
| Secondary | Number of Participants That Discontinued Study Treatment Due to an AE | Up to approximately 24 months | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported per protocol for the first course of treatment. |
| Secondary | Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR | Up to approximately 67 months | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported per protocol for the first course of treatment. |
| Secondary | Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR | Up to approximately 67 months | PFS was defined as the time from first day of study treatment to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 was reported per protocol for the first course of treatment. |
| Secondary | Overall Survival (OS) | Up to approximately 67 months | OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was reported per protocol for the first course of treatment |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) | Up to approximately 28 months | All allocated participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 59 months | All allocated participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Discontinued Study Treatment Due to an AE | Up to approximately 24 months | All allocated participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR | Up to approximately 67 months | All allocated participants who received at least 1 dose of study treatment and who experienced a confirmed CR or confirmed PR. One previously reported participant was excluded from the DOR analysis based on a BICR re-read of prior scans after the primary analysis database lock. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR | Up to approximately 67 months | All allocated participants who received at least 1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 67 months | All allocated participants who received at least 1 dose of study treatment. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) | Pembrolizumab 200 mg | 9.9 | 95% Confidence Interval 5.2 to 16.7 | percentage of participants | |
| Number of Participants Who Experienced an Adverse Event (AE) | Pembrolizumab 200 mg | 116 | Participants | ||
| Number of Participants That Discontinued Study Treatment Due to an AE | Pembrolizumab 200 mg | 14 | Participants | ||
| Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR | Pembrolizumab 200 mg | 19.7 | Full Range 2.1 to 60.3 | Months | |
| Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR | Pembrolizumab 200 mg | 2.0 | 95% Confidence Interval 1.9 to 2.1 | Months | |
| Overall Survival (OS) | Pembrolizumab 200 mg | 5.8 | 95% Confidence Interval 4.5 to 7.2 | Months |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab 200 mg | 121 | |
| Overall Study | Received First Course of Pembrolizumab | Pembrolizumab 200 mg | 121 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab 200 mg | 1 | |
| Overall Study | COMPLETED | Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab 200 mg | 121 |
Source ClinicalTrials.gov
Adverse events182
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab 200 mg First Course | 18 | 121 | 22 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab 200 mg Second Course | 0 | 1 | 0 |
| other | Deafness neurosensory | Ear and labyrinth disorders | Pembrolizumab 200 mg First Course | 0 | 121 | 0 |
| other | Deafness neurosensory | Ear and labyrinth disorders | Pembrolizumab 200 mg Second Course | 1 | 1 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Pembrolizumab 200 mg First Course | 1 | 121 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Pembrolizumab 200 mg Second Course | 1 | 1 | 1 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab 200 mg First Course | 11 | 121 | 13 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab 200 mg Second Course | 0 | 1 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab 200 mg First Course | 9 | 121 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab 200 mg Second Course | 0 | 1 | 0 |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab 200 mg First Course | 116 | 121 |
| Total, all-cause mortality | Pembrolizumab 200 mg Second Course | 0 | 1 |
| Total, other adverse events | Pembrolizumab 200 mg First Course | 107 | 121 |
| Total, other adverse events | Pembrolizumab 200 mg Second Course | 1 | 1 |
| Total, serious adverse events | Pembrolizumab 200 mg First Course | 47 | 121 |
| Total, serious adverse events | Pembrolizumab 200 mg Second Course | 0 | 1 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab 200 mg First Course vs Pembrolizumab 200 mg Second Course: deaths from any cause | Trial comparisons |
| Pembrolizumab 200 mg First Course vs Pembrolizumab 200 mg Second Course: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02559687
GET https://conductscience.org/api/trials/v1/NCT02559687/events?page=2